The present invention relates to the diagnosis and treatment of pelvic organ prolapse and related conditions. The diagnosis and treatment may involve the use of a multiple sensor-enabled device for vaginal insertion capable of providing real-time data regarding the patient's physiology, the position and movement of the urethra, and the muscular strength of the patient's vagina and pelvic floor.
Pelvic organ prolapse (POP) generally relates to a condition where the muscles and ligaments supporting a woman's pelvic organs weaken thereby causing the pelvic organs to slip out of place (prolapse). There are different types of POP, including vaginal vault prolapse, bladder prolapse, rectal prolapse, uterine prolapse, and small bowel prolapse. Some women develop vaginal prolapse, usually after menopause, childbirth or a hysterectomy.
In certain cases, POP occurs due to the damage of the tissues that support the intra-abdominal contents causing the contents of the abdominal cavity to spill through the weakest support points and extrude through the vaginal walls. This weakness can be at the bladder area, the uterine area or the rectal/enterocele area. The condition can worsen over time, and the patient may need corrective surgery.
Information regarding the anatomical areas of weakness suspected as contributing to the condition as well as the primary area of weakness can facilitate appropriate corrective surgery at an early stage and in a targeted fashion to repair the herniated abdominal contents through the pelvic floor area. In addition, specially designed patches, for example, could be used to prevent further prolapse.
Presently, there is no available test that can accurately diagnose POP by localizing and evaluating the herniated areas suspected of giving rise to a patient's POP. The types of diagnostic tests commonly relied upon today include the cotton swab test (where the health care provider inserts a small, cotton-tipped applicator lubricated with anesthetic gel into the patient's urethra, the patient is asked to strain, and the applicator may indicate a loss of support to the urethra); the bladder function test (to measure the ability of the patient's bladder to store and empty urine, which might aid the health care provider to determine the most appropriate type of surgery for bladder or urethral prolapse); pelvic floor strength tests (where the health care provider relies upon personal experience to approximate the strength of the patient's pelvic floor and sphincter muscles, and possibly, the strength of muscles and ligaments that support the patient's vaginal walls, uterus, rectum, urethra and bladder); and imaging tests (which include magnetic resonance imaging (MRI) to obtain a three-dimensional image of the pelvis; ultrasound to visualize the patient's kidneys, bladder or the muscles around the patient's anus; cystoscopy to evaluate symptoms of urinary urgency, frequency, bladder pain or blood in the urine by insertion of a thin tube with a light and camera on the tip (cytoscope) into the patient's urethra to view the urethra and bladder. None of these techniques, however, alone or collectively, can provide the positional and pressure data to yield as detailed and accurate POP diagnosis as possible through the instant invention.
Furthermore, there is evidence that pelvic floor training can strengthen the pelvic floor muscles to remedy or otherwise alleviate urinary incontinence (UI) and POP, and thereby avoid surgery. Present methods for pelvic floor training, however, do not offer a way for the health care provider or the patient to measure improvement, confirm that such exercises are being performed correctly, or to accurately monitor the amount of time the patient is doing the exercises and amount of exertion the patient is using in order to improve or prevent UI or POP.
The multiple sensor-enabled device disclosed here can assist the health care provider and the patient to assess whether the patient is properly performing Kegel exercises and otherwise achieving the therapeutic goals.
Physical therapists today employ certain electronic devices to help the patient perform Kegel exercises. In these cases, a vaginal insert with sensors may be viewed as electrical impulses on a screen. But these devices cannot reflect what muscles the patient is contracting, indicate whether the patient is contracting the appropriate muscles, or monitor the patient's progress. Essentially, the only information readout is a tracing that reflects the discharge of electrical stimuli, but which offers no assurance to the health care provider or patient that the needed strengthening of the pelvic floor muscles is occurring. Electrical stimulation might provide temporary relief of UI if the electrical impulses happen to be engaged and placed correctly. However, because it is difficult, if not impossible, to know the amount of electrical discharge needed and the correct positioning, these methods do not work effectively or long-term. The electrical stimulation might allow the patient to recognize their own muscles, but falls short of facilitating the strengthening of the patient's muscles to result in an improvement, because the patient must also contract the particular muscles properly.
The multiple sensor-enabled device of the instant invention would allow the health care provider and the patient to visualize whether the patient is actually doing the pelvic floor exercises correctly. Moreover, educating the patient on the correct way of using the device would allow the patient to take the device with her, and in the privacy of her home, visualize her exercise regimen through a convenient display, such as a computer or smart phone application. The patient may also benefit from inserting, removing and cleaning the device at her convenience. Furthermore, the patient can monitor and record her progress and send her information back to the health care provider to assure her compliance. The convenience and privacy of home training and progress monitoring can enhance patient compliance with the therapeutic regimen, and facilitate a more efficient achievement of therapeutic goals.